STAT

NOVEMBER 15, 2022

However, a STAT   review of documents detailing   the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants.

Documentation 364

Documentation Vaccines 364

STAT

JULY 15, 2024

WASHINGTON – Top Food and Drug Administration officials met multiple times earlier this year to discuss the regulation of ultra-processed foods, according to internal agency calendars obtained by STAT.

Documentation 363

Documentation 363

STAT

MAY 6, 2024

WASHINGTON – Two New York University professors collaborated directly with executives of the vaping company Juul without disclosing those relationships to academic journals or Congress, a STAT investigation reveals.

Documentation 363

Documentation 363

STAT

APRIL 12, 2023

The settlement, which includes California and New York, is the largest to date between Juul and state attorneys general, and will also require Juul to disclose a number of previously secret documents, which will be housed in an academic archive. Read the rest…

Documentation 240

Documentation 240

STAT

OCTOBER 6, 2022

In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. Food and Drug Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.

Documentation 250

Documentation 250

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 98

Documentation Inpatient 98

STAT

JANUARY 29, 2024

LONDON — There was something odd about these Alzheimer’s cases. Part of it was the patients’ presentations: Some didn’t have the classic symptoms of the condition. But it was also that the patients were in their 40s and 50s, even their 30s, far younger than people who normally develop the disease.

Documentation 364

Documentation 364

RX Note

OCTOBER 9, 2023

Since we don't even remember what we eat this morning, it is vital to make proper medical documentation. The amendments should be documented on the prescription and endorsed with “prescriber contacted” (PC), dated and initialled by the pharmacist/person dispensing.

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Documentation Medical Records 52

STAT

MAY 31, 2024

More than three years ago, the National Institutes of Health launched a $1 billion-plus initiative to find the root causes and potential treatments for long Covid , the chronic disease that has quickly changed the lives of millions of Americans.

Documentation 364

Documentation 364

BioPharma Dive

MAY 10, 2023

Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.

Documentation 119

Documentation 119

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

Documentation 57

Documentation Communication 57

STAT

OCTOBER 27, 2023

The Food and Drug Administration said on Friday that it has some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing the methods used by its makers to evaluate the risk of inadvertently making unwanted changes to patients’ DNA.

Documentation 356

Documentation 356

STAT

MARCH 20, 2024

Johnson & Johnson has accused a long-standing employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer, according to lawsuit filed in a federal court in New Jersey.

Documentation 330

Documentation 330

National Association of Boards of Pharmacy

MARCH 22, 2024

Food and Drug Administration (FDA) has released a final guidance document offering recommendations to sponsors on developing monoclonal antibody products targeting SARS-CoV-2 intended to prevent or treat COVID-19. Additionally, the guidance document lists the criteria needed for FDA to issue emergency use authorizations.

Documentation 52

Documentation 52

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 52

Documentation Inpatient 52

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines 246

Vaccines Documentation 246

PioneerRx

MARCH 8, 2023

Save valuable time in your workflow with the Incoming Documents and Faxes tool, available in PioneerRx’s pharmacy software.…

Documentation 52

Documentation 52

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

pharmaphorum

NOVEMBER 13, 2020

Join us at our 2nd Clinical Document World Virtual event on January 19-21, 2021, alongside your TMF, clinical quality, document management, and clinical professionals to explore a strategic clinical process and ensure a complete Document Management Process. Focus on ensuring high quality documentation.

Documentation 52

Documentation 52

STAT

OCTOBER 14, 2022

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.  

Documentation 307

Documentation 307

STAT

DECEMBER 16, 2022

My grandmother died in the hospital, alone, the day after she was “found down” at home by emergency medical services. I lived near my Nani, as I called her but, even though I am a physician, was not allowed to see her after she had been admitted to her local hospital because of the strict, Covid-related no-visitor policy.

Documentation 267

Documentation Hospitals 267

Pharma Pathway

DECEMBER 14, 2022

Ltd- Walk-In Interview for Production & Documentation On 17th Dec’ 2022. Chemist in Production & Documentation @ Azico Biophore India Pvt. Department: Production & Documentation. Ltd- Walk-In Interview for Production & Documentation On 17th Dec’ 2022. Azico Biophore India Pvt.

Documentation 80

Documentation 80

Pharma Pathway

JANUARY 6, 2023

Walk-Ins for Quality Control/ Production/ Production Documentation/ EHS On 7th Jan’ 2023. Walk-Ins for Quality Control/ Production/ Production Documentation/ EHS On 7th Jan’ 2023. Department: Quality Control/ Production/ Production Documentation/ EHS. Dasami Lab Pvt. Job Description. Dasami Lab Pvt. Dasami Lab Pvt.

Documentation 83

Documentation 83

STAT

SEPTEMBER 18, 2024

billion, according to STAT’s analysis of financial documents the health system released Tuesday evening. The cyberattack that forced Ascension to shut off access to its electronic health records cost the nonprofit hospital system roughly $1.3 Continue to STAT+ to read the full story…

Hospitals 359

Hospitals Documentation 359

Pharma Pathway

SEPTEMBER 17, 2022

Dasami Labs-Walk-In Drive for Quality Control/ Production/ AQA / Production Documentation/ Engineering On 18th Sept’ 2022. Walk-In Drive for Quality Control/ Production/ AQA / Production Documentation/ Engineering On 18th Sept’ 2022 On 18th Sept’ 2022 @ Dasami Labs. Job Description. Greetings from Dasami Labs !!! Contact: 9100037271.

Documentation 89

Documentation 89

Pharmafile

APRIL 25, 2023

The National Institute for Health and Care Excellence (NICE) has submitted a Final Appraisal Document (FAD) for the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. read more

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Documentation Communication 59

BioPharma Dive

SEPTEMBER 1, 2023

The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.

Documentation 60

Documentation 60

Pharma Pathway

JANUARY 5, 2023

SMS Lifesciences India Limited- Walk-In Interviews for Production/ Production Documentation/ Maintenance On 7th Jan’ 2023. Walk-In Interviews for Freshers & Experienced in Production/ Production Documentation/ Maintenance @ SMS Lifesciences India Limited. Departments: Production/ Production Documentation/ Maintenance.

Documentation 73

Documentation 73

Big Molecule Watch

MAY 25, 2023

On May 23, 2023, Amgen filed a motion to intervene in the case “for the limited purpose of invoking the First Amendment and common law rights of public access to judicial records in order to unseal documents that were previously sealed.” common law. The post Amgen Intervenes in Regeneron v.

Documentation 62

Documentation Biosimilars 62

PharmaTech

MARCH 23, 2023

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Documentation 52

Documentation 52

Outsourcing Pharma

JANUARY 28, 2022

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

Documentation 69

Documentation 69

Express Pharma

MAY 19, 2023

“Tweak in policy is mooted,” the document from the prime minister’s office said, adding that “important things” had been “overlooked” It did not elaborate. .” The post India considers policy change after cough syrup deaths, a document from PM’s office appeared first on Express Pharma.

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Documentation Generic Medicine 89

STAT

DECEMBER 28, 2023

Health insurance giant UnitedHealth Group used secret rules to restrict access to rehabilitation care requested by specific groups of seriously ill patients, including those who lived in nursing homes or suffered from cognitive impairment, according to internal documents obtained by STAT.

Nursing Homes 364

Nursing Homes Documentation 364

Syner-G

SEPTEMBER 20, 2023

Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 40

National Association of Boards of Pharmacy

MARCH 22, 2024

Food and Drug Administration (FDA) has issued two draft interim guidance documents that address the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Documentation 52

Documentation Compounding 52

STAT

SEPTEMBER 16, 2024

They dug into a decade of documents from the Food and Drug Administration to understand how devices recalled for their risk of serious injury or death were clinically tested before being used on patients.    In most cases, they simply weren’t.

Documentation 314

Documentation 314

STAT

APRIL 11, 2024

Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT.

Documentation 363

Documentation 363